Quality Investigator I

RoslinCT, Edinburgh, United Kingdom

Overview

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Location: Edinburgh BioQuarter.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science. Find out more about what we do here.

Why join us

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing matters to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

• An exciting opportunity for a Quality Investigator I to join our Operations Quality Improvement Team (OQIT).
• Responsible for performing detailed and thorough investigations of non-compliances by closure date.
• Conduct and summarise technical deviation / incident investigations, translating complex operational events into summary reports.
• Identify realistic by effectual corrective and preventative actions.
• Provide oversight for the development and maintenance of quality programmes, systems, processes and procedures that ensure compliance with internal policies and internal / external standards and guidelines.
• Plan, execute, and lead RCA events with attendance from relevant departments.
• Present technical status updates of RCA and findings to RoslinCT, customers, and regulatory inspectors.
• Provide technical leadership of manufacturing projects and act as the technical point of contact for the client, where appropriate.
• Liaise with Lead Biotechnologists, Supervisors and Trainers to conduct sharing sessions with operators on investigation outcomes, impacts and CAPAs.
• Input into other quality management work such as Change Controls, Risk Assessments, FMEA, document updates and CAPA implementation.

About You

• Proven experience working in a GMP regulated environment, particularly in technical writing.
• Experience of cGMP regulations particularly in respect of aseptic processing, documentation and record management.
• Proficient in Microsoft Office.
• Experience in cell culture methods and techniques.
• Working knowledge of PICS and ISO regulations.
• Excellent attention to detail, with the ability to handle multiple tasks at a given time in a dynamic and changing environment.
• Takes responsibility for continually setting high standards, with a desire to develop and improve processes.
• Exceptional written and verbal communication skills, building effective relationships with various stakeholders.

Next Steps

If this sounds like you, please click Apply and upload your CV and complete a short application detailing why you are interested and why we should hire you.

We’re committed to inclusivity and a fair, welcoming workplace. We are an equal opportunity employer and do not discriminate based on protected characteristics. If you have accessibility needs or concerns regarding the recruitment process, please contact us at jobs@roslinct.com for assistance.